For previously untreated patients with metastatic NSCLC whose tumours express PD-L1 and who do not harbor a sensitizing EGFR mutation or ALK translocation. Funding is being requested for patients with a TPS (Tumour Proportion Score) of PD-L1 ≥50%.

Review Status

Notification to Implement Issued

Pre Noc Submission

Yes

NOC Date

July 12, 2017

Manufacturer

Merck Canada Inc.

Submitter

Merck Canada Inc.

Submission Date

December 12, 2016

Submission Deemed Complete

December 19, 2016

Submission Type

New Indication

Prioritization Requested

Requested and Not Granted

Stakeholder Input Deadline ‡

January 3, 2017

Check-point meeting

February 15, 2017

pERC Meeting

July 20, 2017

Clarification

The Manufacturer has advised that Category 2 submission requirements for a pre-NOC submission will not be available to complete the submission for a June pERC meeting date. An updated target date for the pERC meeting has been set by pCODR, based on the anticipated timing of the manufacturer being able to provide these outstanding submission requirements.

Initial Recommendation Issued

August 3, 2017

Feedback Deadline ‡

August 18, 2017

Final Recommendation Issued

August 23, 2017

Notification to Implement Issued

September 8, 2017

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.